Participating in a Clinical Trial - Part 1
This week I started my first clinical trial that’s a treatment-based study. I only say “treatment based” as there are multiple types of clinical trials. I’m already participating in a supportive care trial that is studying the effects of diet and exercise while on ADT (Androgen Deprivation Therapy). A treatment-based study is what most of us think of when we hear the words “clinical trial.” That is a trial that is testing a particular drug to see how well it works in the treatment of a certain type of cancer.
The study I’m participating in is comparing the efficacy of treatment with Cabazitaxel (Jevtana) and Abiraterone (Zytiga) together vs. Abiraterone alone. Cabazitaxel and Abiraterone are both FDA-approved treatments for prostate cancer, so this trial is really looking at how well they work together.
Why this trial?
This trial is specifically for patients with castrate resistant prostate cancer and who are still on ADT. Unfortunately my prostate cancer has become castrate resistant, which means that even though my testosterone is at a castrate level, my PSA has started to rise despite the treatment. This is due to the fact that my cancer has started to produce its own testosterone. Since I now need to switch to a second-line treatment, I decided to start looking for a clinical trial I may qualify for and this one seemed to be a good fit.
Each trial will have specific eligibility and exclusion criteria. Generally, the eligibility criteria is lengthy, stringent, and explicit. I asked my oncologist about the trial and she thought I would qualify, so at that point, I asked to be added to the trial.
Getting started -- informed consent
My oncologist called in a clinical research coordinator she works with and we sat down to discuss the clinical trial. The coordinator went over the consent form with me (21 pages!), fully explaining the trial at length. This included the purpose of the trial, how the trial works, how long the study will last, if any extra tests or procedures are required, possible side effects and other potential risks, any costs that may not be covered by the study, and the explanation that you can leave the trial at any time. This is called informed consent and is required for any clinical trial.
The entire discussion took us about 15 minutes and I had plenty of time to ask questions. I decided I was ready to start the study right away and signed the consent form then and there. I was given the chance to sleep on it. Clinical trials are completely voluntary so there’s no pressure to join. The doctor from the study then ordered some scans that are required for the trial. This was on a Monday, and a PET scan, CT scan, and bone scan were scheduled by Wednesday. I had the PET scan on Friday and the CT scan and bone scan are scheduled for this coming Wednesday. I’ll meet with my oncologist for a follow up to go over the scan results the Monday after that. (Two weeks from when I signed the consent form.)
This trial is randomized and I should know sometime after I’ve completed the scans which study group I’ve been placed in. It’s a phase 2 trial, so it won’t be a blind study and there are no placebos, meaning I’ll know which treatment I’ll be receiving. This trial has two arms, which is common with this type of trial. Group A will be the study group and those selected for this arm will take Abiraterone and do up to six cycles of Cabazitaxel. Group B will be the control group and will take Abiraterone alone. I’ll go over the scans and the randomized selection in Part 2 (coming soon).
Have you taken the Prostate Cancer Recurrence Quiz yet?